By: Jeffrey M. Gilfor, M.D.

There has been a great deal of misinformation and hearsay associated with reports about cell phones, LAN, and WAN in hospitals. Over the past few months I have been accumulating reports, articles, and data. Now seems the fitting time to report my findings.

First, a bit about jurisdiction:

The FCC has authority over all forms of equipment that is capable to transmit electromagnetic (EM) energy. The FDA has authority over all forms of medical equipment (both disposable and durable), medications, and associated delivery systems or devices.

The FDA has never, and is prohibited from doing so by its charter, banned any communications equipment. They have however, placed pre-market requirements on medical equipment (i.e., shielding requirements).

The FCC has never banned transmitters (of any type) from hospitals; providing that the equipment falls into FCC radiation flux level compliance.

There have been numerous discussions, meetings, publications, and suggestions regarding the use of portable communications equipment in the vicinity of medical equipment over the past 5 or so years. Most of these dealt with problems reported in electric wheelchairs, pacemakers, and anesthesia machines; which, due to inadequate shielding, malfunctioned briefly while exposed to EM interference (EMI).

Apparently, as at least one source states it, a sign company propagated the rumor of an FCC ban on cell phones in hospitals for the purpose of selling its signs. It appears to have worked, and the ban on cell phones in hospitals has grown to become one of the "urban myths" of our society. Again, there is no such ban.

In England, then NHS (National Health Service) issued report DB9702, "Electromagnetic Compatibility of Medical Devices with Mobile Communications." In that 1997 report, only 4% of handheld transmitters (all types) cause any interference at a distance of one meter (3 feet). Based on that report, the agency recommended excluding those devices from "sensitive" areas (OR, ICU, telemetry units). Also, the study stated that, "The type of radio handset made a large difference to the likelihood of interference. At a distance of 1m; 41% of medical devices suffered interference from emergency services handsets, 35% suffered interference from security/porters handsets but only 4% from cellphones. No significant levels of interference were detected from cordless handsets/local area networks or cellular base stations." The report has not been updated.

Participants at the recent Health Canada medical devices roundtable reached several conclusions. They agreed that a total ban of radio-frequency transmitters in hospitals was not justified, and suggested suspectable equipment should be removed if the source of EMI cannot be controlled. They also recommended rational management of wireless telecommunication devices used in hospitals. (Janice Hamilton, "Electromagnetic interference can cause hospital devices to malfunction, McGill group warns;" Canadian Medical Association Journal 1996; 154: 373-375)

Understanding that a ban on cell phones in hospital can not eliminate the EMI constantly surrounding everything in an urban centers, and fearing a backlash of public scrutiny about the issue; Cellular Telecommunications Industry Association, in conjunction with the FDA and FCC, and funded by a grant from Abbott, ran a series of studies (conducted by the University of Oklahoma); to determine what could be done about this problem. The studies concluded that better pre-market testing and more stringent shielding requirements are the answer to preventing EMI from causing medical equipment malfunction. The latest data indicate that concern, especially with newer PCA and spread-spectrum technologies, is overstated. Problems occurred with low frequency (0.6%), only with a small portion of devices used today, and only at very close distances (6") from the devices.

The following are some references:

Newest PCS phones don't interfere with medical equipment (portion follows)

As most TV sit-dram addicts know, things happen fast in hospital emergency rooms. Since a few seconds can make the difference between life and death, decisions must be made "on the fly," and clear, fast communication is a must. But communicating with and keeping track of staff and patients in an "ER" the size of Hennepin County Medical Center's 53,000-square-foot facility is no simple matter. With a number of "team centers" situated throughout the department, "you can't just look down the hall and yell to somebody to help you," said Jan Duroche, assistant nurse manager in the department. Fortunately, HCMC greatly alleviated that concern last year when it joined the growing ranks of Twin Cities hospitals installing in-house cellular phone systems -- augmented by laptop computers and PCs -- to improve staff communication and enhance patient service.

Published in the 6 September 1994 FDA Medical Bulletin.

Therefore, FDA recommends that clinicians and other device users do the following:

• Be aware that EMI can cause steady, momentary, or intermittent disruption of the performance of medical devices.
• Follow the recommendations of the device manufacturer for avoiding EMI.
• Purchase equipment that conforms to EMC standards.
• Consider preventing known sources of interference (e.g., cellular phones, hand-held transceivers) from coming too close to patient monitors and other sensitive electronic medical devices.
• When an EMI problem is suspected, contact the device manufacturer for assistance. Local clinical engineers may also be able to assist in identifying and correcting the problem.
• Report device problems to FDA's MedWatch Program and note if the problem is believed to be linked to interference from a recognizable source of EM energy in the vicinity.

Radiowaves May Interfere with Control of Powered Wheelchairs and Motorized Scooters. Food and Drug Administration (September 20, 1994). 4 pages.

Update on Cellular Phone Interference with Cardiac Pacemakers. Food and Drug Administration (November 1, 1995). 2 pages.

Williams, R.D. Keeping Medical Devices Safe from Electromagnetic Interference. FDA Consumer, Vol. 29, No.4 (May 1995), pp. 12-16.

Witters, D.M. Medical Devices and EMI: The FDA Perspective. ITEM Update (ISBN 1040-4716, 1995), pp. 22-32.